Prescribing Information

Epivir-HBV (lamivudine) Tablets and Oral Solution is a synthetic nucleoside analogue used to treat chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. The tablet form of this medication is available in generic form. Common side effects include ear/nose/throat infections, sore throat, and diarrhea.

The recommended adult oral dosage of Epivir-HBV is 100 mg once daily. Epivir-HBV may interact with trimethoprim or other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Epivir-HBV should be used only if prescribed. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Epivir-HBV (lamivudine) Tablets and Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared with rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

Clinical adverse reactions (regardless of investigator's
causality assessment) reported in greater or equal to 10% of subjects who
received EPIVIR-HBV and reported at a rate greater than placebo are listed in
Table 2.

Table 2: Clinical Adverse Reactionsa Reported in ≥ 10%
of Subjects who Received EPIVIRHBV for 52 to 68 Weeks and at an Incidence
Greater than Placebo (Trials 1-3)

Adverse Event

EPIVIR-HBV
(n = 332)

Placebo
(n = 200)

Ear, Nose, and Throat

Ear, nose, and throat infections

25%

21%

Sore throat

13%

8%

Gastrointestinal

Diarrhea

14%

12%

a Includes adverse events regardless of
severity and causality assessment.

Specified laboratory abnormalities reported in subjects
who received EPIVIR-HBV and reported at a rate greater than in subjects who
received placebo are listed in Table 3.

Table 3: Frequencies of Specified Laboratory
Abnormalities Reported During Treatment at a Greater Frequency in Subjects
Treated with EPIVIR-HBV Than With Placebo (Trials 1-3)a

Test (Abnormal Level)

Subjects With Abnormality/Subjects With Observations

EPIVIR-HBV

Placebo

Serum Lipase ≥ 2.5 x ULNb

10%

7%

CPK ≥ 7 x baseline

9%

5%

Platelets < 50,000/mm³

4%

3%

a Includes subjects treated for 52 to 68 weeks.bIncludes observations during and after treatment in the 2
placebo-controlled trials that collected this information.
ULN = Upper limit of normal.

In subjects followed for up to 16 weeks after
discontinuation of treatment, posttreatment ALT elevations were observed more
frequently in subjects who had received EPIVIR-HBV than in subjects who had
received placebo. A comparison of ALT elevations between Weeks 52 and 68 in
subjects who discontinued EPIVIR-HBV at Week 52 and subjects in the same trials
who received placebo throughout the treatment course is shown in Table 4.

Most commonly observed adverse reactions in the pediatric
trials were similar to those in adult trials. Posttreatment transaminase
elevations were observed in some subjects followed after cessation of
EPIVIR-HBV.

Postmarketing Experience

In addition to adverse reactions reported from clinical
trials, the following adverse reactions have been reported during postmarketing
use of EPIVIR-HBV. Because these reactions are reported voluntarily from a
population of unknown size, it is not always possible to reliably estimate the
frequency or establish a causal relationship to drug exposure. These reactions
have been chosen for inclusion due to a combination of their seriousness,
frequency of reporting, or potential causal connection to lamivudine.